BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3790444 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08518
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37751, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOULD "SWITCH TO A NEW BATTERY, A LARGER ONE." IT WAS REPORTED THE BATTERY WOULD BE REPLACED BECAUSE THE NEUROSTIMULATOR(INS) BATTERY ONLY LASTED FOR A DAY OR TWO, ABOUT A DAY AND A HALF. IT WAS NOTED IF THE PATIENT DID NOT CHARGE EVERY DAY THE INS BATTERY DIED. IT WAS NOTED THAT PROBLEM STARTED ABOUT 6 MONTHS PRIOR TO REPORT. IT WAS REPORTED THE PATIENT WAS SUPPOSED TO HAVE THE INS CHANGED A WHILE BACK, BUT HE WAS NOT ABLE TO GET IT DONE YET. IT WAS LATER REPORTED ON (B)(6) 2014 INS BATTERY DEPLETION. THE INTERNAL UNIT HOLDS A CHARGE BUT THE PATIENT WAS GETTING A NEW CANISTER ON (B)(6) 2014. THE INS WAS BEING CHANGED BECAUSE THE CHARGE ONLY LASTS A DAY IN THE INS AND THEY ARE GOING TO IMPLANT ONE THAT WILL LAST ABOUT A WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267940 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention